FDA.reportPublic FDA data

Application 761262

Type
BLA
Sponsor
ABBVIE INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SKYRIZIRISANKIZUMAB-RZAAINJECTABLE;SUBCUTANEOUS150MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0074-5015Skyrizirisankizumab-rzaaAbbVie Inc.BLACurrent
0074-5015Skyrizirisankizumab-rzaaAbbVie Inc.BLACurrent
0074-5015Skyrizirisankizumab-rzaaAbbVie Inc.BLACurrent
0074-5015Skyrizirisankizumab-rzaaAbbVie Inc.BLACurrent
0074-5015Skyrizirisankizumab-rzaaAbbVie Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85491SUPPL 2026-03-24
85438SUPPL 2026-03-20
85344SUPPL 2026-03-12
85309SUPPL 2026-03-09
83297SUPPL 2025-09-05
83296SUPPL 2025-09-05
83282SUPPL 2025-09-04
82182SUPPL 2025-05-14
78858SUPPL 2024-06-20
78848SUPPL 2024-06-20
77730SUPPL 2024-03-06
77720SUPPL 2024-03-05
77187SUPPL 2024-01-04
77181SUPPL 2024-01-04
73803ORIG 2023-03-20
72744ORIG2022-11-28
72158SUPPL2022-09-27
72157SUPPL2022-09-27
72154SUPPL2022-09-26
71361ORIG2022-06-21
71357ORIG2022-06-21
71352ORIG2022-06-17